Search results for " manufacturing" in Articles / App Notes

Article Quality by design for biotechnology products—part 1
…uding incorporating QbD into a regulatory filing and facilitating efficient commercial processes and manufacturing change flexibility post licensure. Quality by Design (QbD) is a concept applied…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Provided is a comprehensive, risk-based transgene characterization strategy; its implementation is based on chemistry, manufacturing, and control (CMC) development phases to ensure that the integrity …

Article New Therapies Present Scaling Challenges
…ll and gene therapies—presents challenges and decisions for drug companies looking to increase the manufacturing volumes of these specialized therapeutics. However, differences in manufacturing cycle…

Article Genetic Vaccine Platforms Demonstrate Their Potential
  Development and manufacturing advantages for genetic vaccines    What makes genetic vaccines so attractive is the potential to establish platform solutions that allow the r…

Article Supply Chain Challenges for Single-Use Systems
By Jennifer Markarian  The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative to or in combination with traditional stainless-steel equipment o…

Article Reducing Cross-Contamination Risks in Process Chromatography
Today, single-use bioreactors are widely used for biologic drug manufacturing, and downstream disposable technologies for commercial-scale production operations are being introduced and increasingly a…

Article Design and Qualification of Single-Use Systems
Martin Single-use technologies (SUT) have made significant inroads in biopharmaceutical and vaccine manufacturing. Greater adoption in the years to come can be anticipated, given their broad use i…

Article Technologies and Practices Must Evolve to Meet Demand
In the annual Manufacturing Trends and Outlook survey, the editors of BioPharm International polled bioprocessing development and manufacturing experts to assess challenges, preferences for different …

Article PDA's Technical Report for Biotech Cleaning Validation
Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately an…

Article Mapping a Route for Cell and Gene Therapy Process Development
These products are highly complex and often involve production methods that, while in some ways are similar to those used in biologics and vaccine manufacturing, in many ways are quite different. …

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